The Journal of Bone and Joint Surgery 83:336 (2001)
© 2001 The Journal of Bone and Joint Surgery, Inc.
Prolonged Enoxaparin Therapy to Prevent Venous Thromboembolism After Primary Hip or Knee Replacement
Philip C. Comp, MD, PhD,
Theodore E. Spiro, MD,
Richard J. Friedman, MD,
Thomas L. Whitsett, MD,
Gerhard J. Johnson, MD,
Geoffrey A. Gardiner, Jr, MD,
Glenn C. Landon, MD and
Maurice Jové, MD, Enoxaparin Clinical Trial Group
A commentary is available with the electronic versions of
this article, on our web site (www.jbjs.org) and on our CD-ROM (call
781-449-9780, ext. 140, to order).
Philip C. Comp, MD, PhD
Department of Medicine, The University Hospitals, 800 N.E. 13th
Street, Room EB400, Oklahoma City, OK 73126. E-mail address: philip-comp{at}uokhsc.edu
Theodore E. Spiro, MD
Cardiovascular Therapeutic Area, European Operations Site, E2/309,
Aventis Pharma, 20 Avenue Raymond Aron, 92160 Antony, France. E-mail address:
theodore.spiro@aventis.com. Please address correspondence
and requests for reprints to T.E. Spiro.
Richard J. Friedman, MD
Medical University of South Carolina, 171 Ashley Avenue, Charleston,
SC 29425
Thomas L. Whitsett, MD
Department of Medicine, University of Oklahoma Health Sciences Center,
Room 3120, 920 Stanton L. Young Boulevard, Oklahoma City, OK 73104
Gerhard J. Johnson, MD
Veterans Administration Medical Center, One Veterans Drive, Minneapolis,
MN 55417. E-mail address: johns337@maroon.tc.umn.edu
Geoffrey A. Gardiner Jr., MD
Department of Radiology, Thomas Jefferson University Hospital, Suite
4200, Gibbons Building, 111 South 11th Street, Philadelphia, PA
19107
Glenn C. Landon, MD
Kelsey-Seybold Clinic, St. Luke’s Medical Tower, 6624 Fannin
Street, Houston, TX 77030
Maurice Jové, MD
Atlanta Knee and Sports Medicine, 2801 North Decatur Road, Suite
200, Decatur, GA 30033
One or more of the authors has received or will receive benefits
for personal or professional use from a commercial party related
directly or indirectly to the subject of this article. Funds were received
in total or partial support of the research or clinical study presented
in this article. The funding source was Aventis Pharmaceuticals,
Incorporated, Bridgewater, New Jersey, and Aventis Pharma, S.A.,
Antony, France, formerly Rhône-Poulenc Rorer Pharma, S.A.,
Collegeville, Pennsylvania, and
Antony, France.
Background: Patients undergoing hip or knee
joint replacement are at risk for venous thromboembolic complications
for up to twelve weeks postoperatively. We evaluated the efficacy
and safety of a prolonged post-hospital regimen of enoxaparin, a
low-molecular-weight heparin, in this patient population.
Methods: Following elective total hip or knee replacement, 968
patients received subcutaneous enoxaparin (30 mg twice daily) for
seven to ten days, and 873 were then randomized to receive three
weeks of double-blind outpatient treatment with either enoxaparin (40
mg once daily) or a placebo. The primary efficacy end point was
the prevalence of objectively confirmed venous thromboembolism or
symptomatic pulmonary embolism during the double-blind phase of
treatment.
Results: Of the 873 randomized patients, 435 underwent elective
total hip replacement and 438 underwent elective total knee replacement.
Enoxaparin was superior to the placebo in reducing the prevalence of
venous thromboembolism in patients treated with hip replacement:
8.0% (eighteen) of the 224 patients treated with enoxaparin
had venous thromboembolism compared with 23.2% (forty-nine)
of the 211 patients treated with the placebo (p < 0.001; odds
ratio, 3.62; 95% confidence interval, 2.00 to 6.55; relative
risk reduction, 65.5%). Enoxaparin had no significant benefit
in the patients treated with knee replacement: thirty-eight (17.5%)
of the 217 patients treated with enoxaparin had venous thromboembolism
compared with forty-six (20.8%) of the 221 patients treated
with the placebo (p = 0.380; odds ratio, 1.24; 95% confidence
interval, 0.76 to 2.02; relative risk reduction, 15.9%). Symptomatic
pulmonary embolism developed in three patients, one with a hip replacement
and two with a knee replacement; all had received the placebo. There
was no significant difference in the prevalence of hemorrhagic episodes
or other types of toxicity between the enoxaparin and placebo-treated
groups.
Conclusions: Prolonging enoxaparin thromboprophylaxis
following hip replacement for a total of four weeks provided therapeutic
benefit, by reducing the prevalence of venous thromboembolism, without
compromising safety. A similar benefit was not observed in patients
treated with knee replacement.
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